Growing regulatory pressure and the challenge of litigation over adverse or side effects, rapidly changing demographic patterns, dwindling product pipelines, and consistent growth in competition from generic manufacturers are just a few of the major challenges confronting the life sciences industry.
Further growth in the cost of drug development, approvals and growing responsibilities and obligations on the regulatory front have driven organizations to adopt outsourcing services for regulatory operations. These activities are proven to result in improved cost efficiencies while manufacturers become more focused on their core competencies. Diversification of several ancillary activities allows organizations to focus on improving their core businesses while third-party vendors deliver optimal services.
Some major advantages derived from regulatory affairs outsourcing include increased speed of market approvals, effective maintenance of product success in new and emerging markets, and swift and convenient extension of brand indications and formulations. Regulatory affairs outsourcing is also a high advantage for midsize and small companies that lack expertise in certain departments. This also reduced the workload on the employees and management while also ensuring appropriate, timely, and prompt regulatory submissions.
Market Synopsis
Regulatory writing and publishing are expected to be the major revenue generators, while clinical trial and product registration services will pick up pace within the forecast period.
Among the major regulatory affairs outsourcing services, regulatory writing and publishing occupy the largest revenue share in the global market. As the global market is condensing, there is prominent visibility of distinct regulatory scenarios in different regions. Companies domiciled in Europe and North America often face challenges in terms of regulatory submissions to emerging markets in the Asia Pacific, the Middle East, and Africa.
Regulations around the world are also changing quickly as a result of increased interest in ensuring the rapid commercialization of products with assured safety profiles. Therefore, it has become imperative for manufacturers to provide timely data updates for regulatory submissions and literature. Furthermore, it is anticipated that the market for clinical trials and product registration services will witness rapid growth during the forecast period.
Impending patent expiries and the increasing focus of drug manufacturers on delivering drugs for rare diseases have prompted the emergence of a pipeline for specialty drugs. With an increase in the number of such drug candidates, the demand for clinical trial and product registration services will rise in the coming years.
Asia-Pacific will be the global outsourcing center.
The manufacturers of several blockbuster drugs are domiciled in Europe and North America, where the patents for such drugs are rapidly expiring. Several of these manufacturers have increased their efforts to introduce their drugs and medical devices to Asia Pacific's emerging markets in order to extend the product life cycle. Companies are capitalizing on the potential of emerging economies to introduce their products and services into developed markets.CDMO and regulatory outsourcing activities are being increasingly set up in emerging economies due to cheap labor, improved skills, and low service costs.
Periods of History and Forecast
This research report presents the analysis of each considered segment for the period from 2016 to 2026, using 2017 as the base year for estimations. Compounded annual growth rates (CAGRs) for each segment are calculated for the forecast period from2018 to 2026.
Report Scope by Segments
The Regulatory Affairs Outsourcing Services market report provides a quantitative assessment of the industry in terms of current and forecasted market size while also presenting the market dynamics. This market is segmented based on types, usage areas, and geography.
This report also includes a company profiles section that gives insights into the company overview, product portfolio, financial information, and key developments of major market players. The major players profiled in this report include ICON plc, Quintiles Transnational Corporation, PAREXEL International Corporation, Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., Accell Clinical Research, LLC, Criterium, Inc., Medpace, Inc., Promedica International, WuXi App Tec, Genpact Ltd., PRA Health Sciences, Inc., and Pharmaceutical Product Development (PPD), LLC.
Key questions are answered in this report.
What is the current and projected size of the global market for regulatory affairs outsourcing services through 2026?
Which are the key trends observed in the global market, along with the most prominent growth facilitators?
What are the major strategic initiatives undertaken by the major market participants to ensure global market stability?
What are the key contributing factors to the dominance of North America and Europe in the global market?
Which factors contribute to the rapid growth of the Asia-Pacific market?
Which service type is currently in huge demand from drug manufacturers and why?
Frequently Asked Question:
The market for Regulatory Affairs Outsourcing Services Market is expected to reach USD$ XX in 2026.
The Regulatory Affairs Outsourcing Services Market is expected to see significant CAGR growth over the coming years, at XX%.
The report is forecasted from 2018 -2026.
The base year of this report is 2017.
PAREXEL International Corporation, Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., Accell Clinical Research, LLC. are some of the major players in the global market.
